ROHO QUADTRO SELECT HIGH PROFILE Cushion QS1010CRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00613732054304), received between Nov 13, 2025 and May 15, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2026Material Puncture/Hole

  USER'S CAREGIVER CALLED THAT HER HUSBANDS ROHO QUAD SECECT CUSHION HAD STOPPED HOLDING AIR IN THE RIGHT REAR QUADRANT. DURING THE TIME THE CAREGIVER WAS AWAY FROM THE HOUSE FOR WORK, HER HUSBAND DEVELOPED A PRESSURE SORE FROM SITTING ON THE FLAT QUADRANT.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 25191060 ↗
• InjuryFeb 20, 2026Material Puncture/Hole; Material Perforation; Material Integrity Problem

  END USER RECEIVED A NEW ROHO CUSHION THROUGH THEIR DEALER, NATIONAL SEATING AND MOBILITY. ON FIRST DAY OF USE, THE CUSHION DID NOT HOLD AIR. THE USER SAT ON THE IMPROPERLY INFLATED CUSHION ALL DAY AND DEVELOPED A STAGE 1 PRESSURE SORE, CAUSING HIM TO BE RESTRICTED TO BED REST AND MISS WORK. THE CUSHION WAS REPLACED AND THE SUSPECT CUSHION WAS RETURNED TO ROHO, INC. FOR INSPECTION. UPON INSPECTION, A MANUFACTURING DEFECT WAS IDENTIFIED WHICH LED TO THE LEAKING CUSHION. THE DEFECT OBSERVED IS CLASSIFIED AS A BLISTER. A BLISTER IS AN AIR POCKET WHICH FORMS DURING THE NEOPRENE FORMING PROCESS. BLISTERS ARE TYPICALLY FOUND DUIRNG THE INSPECTION PROCESS THROUGH VISUAL INSPECTIONS AND/OR THE OVERINFLATION TEST. OVER INFLATION TESTING IS DESIGNED TO SIMULATE THE PRESSURE OF A PERSON SITTING ON THEIR CUSHION, WHICH WILL TYPICALLY CAUSE BLISTERS TO RUPTURE AND LEAK.

  Patient problems: Pressure Sore/Ulcer; Tissue Breakdown

  MAUDE report 24400017 ↗
• InjuryNov 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  USER CALLED IN WITH A COMPLAINT THAT HIS QS1010C CUSHION IS LEAKING. HE HAS DEVELOPED A PRESSURE SORE FROM SITTING ON A FLAT CUSHION.

  Patient problems: Pressure Sore/Ulcer

  MAUDE report 23550220 ↗